GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT00576758
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • obinutuzumab (RO5072759) — DRUG
    1000 mg obinutuzumab intravenous (IV) infusion once a week for 4 weeks.
  • rituximab — DRUG
    375 mg/m\^2 rituximab IV infusion once a week for 4 weeks.

Study Details

This study will investigate the efficacy of weekly intravenous obinutuzumab \[GA101 (RO5072759)\] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma. Patients will be randomized to receive either GA101 or rituximab, given as four weekly infusions. At the conclusion of the initial trial patients may be eligible to continue therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the target sample size is 100-500 individuals.

Key Dates

Start date
Jan 31, 2008
Status verified
Aug 2014
Primary completion
Sep 30, 2011
Completion
Mar 31, 2013

Study Design

Enrollment
175 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Obinutuzumab
    Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
  • Active Comparator: Rituximab
    Participants received 375 mg/m\^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m\^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.

Primary Outcome Measure

Percentage of Participants With Overall Response At the End of Induction Period [ Time Frame: Randomization to clinical cutoff: 01 September 2011 (Up to 70 days) ]

Locations (13)

FacilityCityStateZIPSite coordinators
-Los AngelesCalifornia90024-
-DenverColorado80220-
-GainesvilleFlorida32610-
-TampaFlorida33612-
-AugustaGeorgia30912-
-CumberlandMaryland21502-
-HackensackNew Jersey07601-
-New YorkNew York10065-
-RochesterNew York14642-
-ConcordNorth Carolina28025-
-ColumbusOhio43219-
-HoustonTexas77030-
-SeattleWashington98109-

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